Patients were instructed to indicate the time they felt the first onset of any analgesic effect

Measured variables included pain ratings and sense of well-being

Results

A total of 42 OFTC administrations were given over the 2 day study period

A mean dose of 12.33 g/kg was used in each OFTC administration

There were no complications requiring any form of intervention or any interruption of the OFTC use, though respiratory rates and blood pressures were noted to drop within the first 60 minutes of administration

None of the study patients requested any other type of analgesia for breakthrough pain

Significant reduction in pain scores were seen at all evaluations from 5 to 120 minutes after administration

Average time of onset was 9.5 minutes with a range of 5-13 minutes

Well-being was significantly increased at all of the evaluations

Author's Conclusions

OFTCs resulted in a consistent and rapid onset of analgesia

OFTC may be a safe and effective analgesia method for breakthrough pain in cancer patients

Scientific Implications

The vast majority of patients with advanced cancer experience pain as a symptom. Although a baseline level of analgesic medication can be given to reduce this pain, breakthrough pain is still likely to occur. The time to treatment of this pain is extremely important. OFTC has been developed since it has a very rapid onset. This study reports on the efficacy and safety of OFTC in patients with advanced cancer. It was shown that in their patient population, OFTC was efficacious and safe as demonstrated by the fact that no intervention as required for toxicity and no other analgesic medication was required for pain relief. While this is encouraging, it should be pointed out that this study was done in only 10 patients only over 2 days. Also, there was no comparison to other analgesic medication or even placebo. Therefore, the placebo effect cannot be estimated at all. However, in this patient population who may have been selected not to respond to narcotics, (as they were dissatisfied with their current regimen), the onset of analgesia was rapid and seemingly complete. Therefore, in this advanced cancer population where pain relief is a large concern, OFTC may be a very useful medication.